title: Pilot trial: pregabalin on colonic sensorimotor functions in irritable bowel syndrome.
abstract: BACKGROUND
  In prior studies, pregabalin reduced rectal or colonic pain in patients with irritable bowel syndrome and healthy adults, suggesting reduction of afferent function.
  
  
  OBJECTIVE
  To assess effects of pregabalin on colonic compliance, sensory and motor functions in patients with constipation-predominant irritable bowel syndrome.
  
  
  METHODS
  In a pilot, double-blind, placebo-controlled, parallel-group study, we tested oral pregabalin, 200mg, in 18 patients with constipation-predominant irritable bowel syndrome. With a barostatically controlled polyethylene balloon in the left colon, we assessed sensation thresholds and colonic compliance using ascending method of limits, sensation ratings over 4 levels of distension, fasting and postprandial colonic tone and phasic motility. Analysis of covariance (adjusted for the corresponding pre-drug response) was used to compare placebo and pregabalin. After 45% participants completed studies, we conducted an interim analysis to assess the conditional power to detect pre-specified treatment effects given the observed variation and treatment group differences based on the planned sample size for the trial.
  
  
  RESULTS
  Pregabalin did not significantly affect colonic compliance, sensation thresholds, sensation ratings, fasting or postprandial tone or motility index. The study was stopped for futility to detect an effect on visceral pain with the planned design and sample size.
  
  
  CONCLUSIONS
  Pregabalin, 200mg, might not reduce distension-related colonic pain in constipation-predominant irritable bowel syndrome patients.
authors.affiliation: Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), College of Medicine, Mayo Clinic, Rochester, MN, United States; Division of Gastroenterology and Hepatology, College of Medicine, Mayo Clinic, Rochester, MN, United States.
authors.forename: Johanna
authors.initials: J
authors.lastname: Iturrino
authors.affiliation: Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), College of Medicine, Mayo Clinic, Rochester, MN, United States; Division of Gastroenterology and Hepatology, College of Medicine, Mayo Clinic, Rochester, MN, United States. Electronic address: camilleri.michael@mayo.edu.
authors.forename: Michael
authors.initials: M
authors.lastname: Camilleri
authors.affiliation: Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), College of Medicine, Mayo Clinic, Rochester, MN, United States; Division of Gastroenterology and Hepatology, College of Medicine, Mayo Clinic, Rochester, MN, United States.
authors.forename: Irene
authors.initials: I
authors.lastname: Busciglio
authors.affiliation: Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), College of Medicine, Mayo Clinic, Rochester, MN, United States; Division of Gastroenterology and Hepatology, College of Medicine, Mayo Clinic, Rochester, MN, United States.
authors.forename: Duane
authors.initials: D
authors.lastname: Burton
authors.affiliation: Department of Health Sciences Research, Division of Biomedical Statistics and Informatics, College of Medicine, Mayo Clinic, Rochester, MN, United States.
authors.forename: Alan R
authors.initials: AR
authors.lastname: Zinsmeister
mesh_terms: D000328:Adult; D000700:Analgesics / Q000627:therapeutic use*; D003106:Colon; D003187:Compliance; D003248:Constipation / Q000150:complications; D004311:Double-Blind Method; D005260:Female; D005769:Gastrointestinal Motility; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010865:Pilot Projects; D000069583:Pregabalin; D012677:Sensation; D012684:Sensory Thresholds; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000700:Analgesics; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid
keywords: Analgesia; Colonic compliance; Gas sensation; Pain sensation